This study is designed to evaluate the safety and efficacy of oral glibenclamide in acute ischemic stroke patients who under intravenous rt-PA thrombolysis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
306
Glibenclamide is administered with a loading dose of 1.25 mg within 10 hours of stroke onset, orally or through gastric tube, followed by 0.625 mg every 8 hour for 5 days.
Placebo is administered with a loading dose of 1.25 mg within 10 hours of stroke onset, orally or through gastric tube, followed by 0.625 mg every 8 hour for 5 days.
Huadu District People's Hospital of Guangzhou
Guangzhou, Guangdong, China
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, China
Heyuan People's Hospital
Heyuan, Guangdong, China
Maoming People's Hospital
Maoming, Guangdong, China
Functional outcome: The proportion of mordified Rankin Scale of 0 to 2 points
The proportion of mordified Rankin Scale of 0 to 2 points at 90 days
Time frame: 90 days after the stroke onset
Early improvement: The proportion of NIHSS decreased ≥ 4 points
The proportion of NIHSS decreased ≥ 4 points at 7 days
Time frame: 7 days after the stroke onset
Hemorrhagic transformation: The proportion of parenchymal hemorrhagic transformation in cranial CT
The proportion of parenchymal hemorrhagic transformation in cranial CT within 96 hours
Time frame: 96 hours after the stroke onset
Midline shift: The proportion of midline shift ≥ 6 mm in cranial CT
The proportion of midline shift ≥ 6 mm in cranial CT within 96 hours
Time frame: 96 hours after the stroke onset
Functional outcome 2: The modified Rankin Scale distribution
The modified Rankin Scale distribution at 90 days
Time frame: 90 days after the stroke onset
Functional outcome 3: The proportion of Barthel Index of 60-100 points
The proportion of Barthel Index of 60-100 points
Time frame: 90 days after the stroke onset
Functional outcome 4: The proportion of IQCODE of ≤ 3.40
The proportion of Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) of ≤ 3.40 at 6 months and 1 year after the stroke onset
Time frame: 6 months and 1 year after the stroke onset
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Maoming Traditional Chinese Medical Hospital
Maoming, Guangdong, China
Hainan Provincial Hospital of Traditional Chinese Medicine
Haikou, Hainan, China
Haikou People's Hospital
Haikou, Hainan, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Jiangsu, China
Blood-brain barrier: The serum concentration of MMP-9
The serum concentration of MMP-9 at baseline, and at 24, 48, and 72 h
Time frame: Baseline, 24, 48, and 72 hours after the stroke onset